LifeVest Wearable Defibrillator
FDA premarket approval P010030/S104 · decided 2018-09-21
Approval details
- PMA number
- P010030
- Supplement
- S104
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LifeVest Wearable Defibrillator
- Generic name
- Wearable automated external defibrillator
- Applicant
- Zoll Manufacturing Corporation
- Date received
- 2018-04-24
- Decision date
- 2018-09-21
- Days to decision
- 150 days
- Decision code
- APPR
- Product code
- MVK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pittsburgh, PA
- Statement
- Approval for minor mechanical design change to the LifeVest Model 4000 Electrode Belt involving addition of epoxy to secure unused wires.
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